KR20140137417A - Hollow fiber membrane module - Google Patents

Abstract

Provided is a hollow fiber membrane module having a structure that is excellent in liquid tightness and high in bonding strength of a welded portion and can be efficiently produced. A membrane fastening layer 5 for fastening the hollow fiber membrane bundle 4 to the inner wall of the end portion of the main body case 4, a main body case 3 for housing the hollow fiber membrane bundle 4, And a header (8, 9) having an inlet (6) or outlet (7) for the liquid to be treated attached to the opening end. The ultrasonic welding of the headers 8, 9 and the main body case 3 in at least two areas over the entire circumference is performed by ultrasonic welding the side surface of the main body case and the inner side surface of the header over the entire circumference. A butt joint is used as a joint design in which a sheath joint is used and the end face of the main body case and the inner side face of the header are ultrasonic welded all over the periphery.

Description

[0001] HOLLOW FIBER MEMBRANE MODULE [0002]

The present invention relates to a hollow fiber membrane module, and more particularly, to a hollow fiber membrane module suitable for blood purification, a plasma separator, and the like.

As is well known in the art, a hollow fiber membrane module using a hollow fiber membrane is used for purifying blood, for example, for dialysis of blood. The hollow fiber membrane module includes a cylindrical body case having a treatment liquid inlet port on an outer peripheral surface at one end and a treatment liquid outlet port at an outer peripheral surface of the other end, a hollow fiber membrane bundle inserted into the body case, And a film fixing layer which fixes the bundle at the end portion to the inner wall of the main body case, and a header is fixed to the opening end portion of the main body case. When the dialysis solution is to be used for dialysis of blood, a dialysis solution (treatment solution) is introduced from the treatment solution inlet port and is led out from the treatment solution outlet port so as to flow into the main body case and the blood (treatment solution) Dialysis of blood is performed by circulating the inside of the hollow fiber membrane toward the port.

In such a dialysis process, it is necessary to liquid-tightly seal the hollow fiber membrane module so that the liquid to be treated (blood) flowing through the hollow fiber membrane module from the junction of the header and the main body case does not leak. Therefore, a method of bonding the header and the main body case using ultrasonic welding has been widely used. The bonding method by ultrasonic welding uses a tool horn to pressurize the head surface of the header and apply ultrasonic vibration while contacting the bonded portion of the header to the bonded portion of the cylindrical body case to transmit vibration to the bonded portion And the bonded portions are mutually heated and melted to be bonded to each other. This method is widely used because it can be stably sealed even in a container requiring airtightness and liquid tightness.

For example, Patent Document 1 discloses a method of ultrasonic bonding a main container and a header between an outer peripheral portion of a main container and a header inner soluble value portion, and then using a horn having a tapered shape, And the header is ultrasonically welded from the side of the main container. However, the joint reinforcement method disclosed in Patent Document 1 requires ultrasonic welding to be performed twice, and the productivity is low, which is not an efficient joint reinforcement method.

The method disclosed in Patent Document 1 is a method in which ultrasonic welding is applied to the main container 31 and the header 32 at two places 33 and 34 as shown in Fig. 7, but two ultrasonic waves It is possible to suppress the intrusion of blood introduced under pressure from the blood introduction port of the header 32 into the slight gap 36 between the header 32 and the membrane-immobilization layer 35 even if the fusion portions 33 and 34 are provided There is no number.

Japanese Patent No. 4842419 Specification

The present invention has been made in view of the above disadvantages of the prior art, and an object of the present invention is to provide a hollow fiber membrane module having a structure that is excellent in liquid tightness and high in bonding strength of a welded portion, It is on.

In order to achieve the above object, the hollow fiber membrane module of the present invention comprises a hollow fiber membrane bundle, a main body case for containing the hollow fiber membrane bundle, a membrane fixing layer for fixing the hollow fiber membrane bundle to the inner wall of the main body case end, And a header having an inlet or an outlet for an object to be treated adhered to the main body case, wherein the header and the main body case are ultrasonically welded in at least two areas extending over the entire periphery, As a joint design for ultrasonic welding the side surface of the outer periphery of the main body case and the inner side surface of the header over a whole circumference, a sheath joint is used and a butt joint is used to ultrasonic weld the end surface of the main body case and the inner side surface of the header. And the like.

In addition, it is natural that the ultrasonic welding is performed here, but the joint is welded in the state where there is no problem such as bubble or crack, and the inner peripheral surface of the header is in contact with the film fixing layer over the entire circumference.

The sectional area obtained by multiplying the width of the joint in the above-described shear joint by the height is preferably 0.3 to 0.9 mm 2, more preferably 0.4 to 0.7 mm 2. If it is less than 0.3 mm < 2 >, it becomes difficult to obtain sufficient strength for bonding. On the other hand, if it exceeds 0.9 mm 2, the energy required for melting increases and it becomes difficult to melt. The width of the shear joint is preferably 0.25 mm or more. If it is less than 0.25 mm, the sheer joint of the header may be opened by elastic deformation in the outer circumferential direction, and the header and the case of the body may not substantially overlap and substantially not be welded together.

The distance between the innermost periphery of the butt joint and the inner periphery of the header in the horizontal direction is preferably 0.5 to 2.0 mm, more preferably 1.0 to 2.0 mm. The shorter the distance in the horizontal direction, the better the liquid tightness by the butt joint, but at least 0.5 mm is required from the technical limit. However, if it is longer than 2.0 mm, improvement of the liquid tightness by the butt joint can not be expected.

The area of the triangle obtained by multiplying the width of the director in the butt joint by the half of the height is preferably 0.05 to 0.35 mm 2, more preferably 0.1 to 0.2 mm 2. The area of this triangle is intended to be the cross-sectional area of the joint portion in the director. When the area is less than 0.05 mm < 2 >, the header and the main body case are not sufficiently melted and the director is pressed against the end surface of the case, and sufficient strength is not obtained for joining. On the other hand, if it exceeds 0.35 mm 2, the energy required for melting increases and it becomes difficult for the director to be melted. In addition, if the angle of the tip of the director (? 1 in FIG. 2 (b)) is 40 to 70 degrees, stress is concentrated on the tip and is easily melted.

It is preferable that the butt joint has resin reservoirs on both the inner circumferential side and the outer circumferential side. This is because the molten resin is received in the resin reservoir and ultrasonic welding is preferably performed.

A membrane-fixing layer for fixing the hollow fiber membrane bundle to the inner wall of the end portion of the main body case; and an inlet or outlet for introducing the liquid to be adhered to the case opening end, Wherein the side face of the outer periphery of the main body case and the inner side face of the header are bonded to the entire periphery of the main body case by ultrasonic welding in at least two areas extending over the entire periphery of the header and the main body case. Ultrasonic welding is carried out using a shear joint, and ultrasonic welding is carried out using a butt joint over the entire circumference of the end surface of the main body case and the inner surface of the header.

A plurality of hollow fiber membranes made of a polymer for hollow fiber membranes are bundled and inserted into a main body case, a membrane fixing layer cap is attached to the end of the main body case, and then a membrane fixing layer polymer is injected into the main body case end, The bundle is fixed to the main body case, the membrane-fixing layer is partially cut so that both end faces of the hollow fiber membrane bundle are opened outward after the film-fixing layer is solidified, and the main body case and the header Characterized in that the inner surface of the header is in contact with the end face of the membrane-immobilized layer not cut in the hollow fiber membrane module manufactured by ultrasonic welding at least two regions.

(Effects of the Invention)

According to the present invention, it is possible to provide a hollow fiber membrane module having a structure that is excellent in liquid tightness and can be efficiently manufactured because the bonding strength of the welded portion is high.

1 is a side cross-sectional view illustrating one embodiment of the hollow fiber membrane module of the present invention.
Fig. 2 (a) is an enlarged view of a part of Fig. 1 showing a main part of the present invention, Fig. 2 (b) is an enlarged view of a part surrounded by a circle in Fig. And a reverse taper formed on the film-fixing layer in contact with the inner surface of the header.
3 is a schematic cross-sectional view showing an example of a shear joint.
4 is a schematic sectional view showing an example of a butt joint.
5 is a schematic side view illustrating an ultrasonic welding apparatus.
6 is a side sectional view showing a state in which a cap is mounted on the end face of the main body case;
7 is a side cross-sectional view showing an example of a hollow fiber membrane module for describing a joint reinforcing method disclosed in Patent Document 1. [

The hollow fiber membrane module of the present invention can be applied to a medical module such as a hemodialyzer, a plasma separator, a plasma component separator, a blood filter, a plasma component adsorber, an artificial lung, and an endotoxin removing filter typified by a hollow fiber membrane type artificial kidney An adsorption module packed with an adsorbent material, and a module for a filtration device.

One embodiment of the hollow fiber membrane module of the present invention will be described with reference to the drawings.

FIG. 1 shows an embodiment in which the hollow fiber membrane module according to the present invention is used as a hemodialyzer, and preferred embodiments and examples are not limited thereto. 1, the hollow fiber membrane module has a treatment liquid inlet port 1 near one end in the longitudinal direction thereof and a cylindrical body 2 having an outlet port 2 for treatment liquid near the other end thereof. A hollow fiber membrane bundle 4 having a case 3 and a plurality of hollow fiber membranes in which the hollow fiber membranes 3 are inserted in one direction and a hollow fiber membrane bundle 4, And a film-fixing layer 5 fixed to the inner wall of the film-fixing layer 5. A header 8 as a lid having an inlet port 6 for blood as a liquid to be treated and an outlet port 7 for blood as a liquid to be treated are provided at the end of the main body case 3, (9) is welded and fixed by the ultrasonic bonded portion (10).

Materials of the main body case and the headers are not limited, but plastics such as polypropylene, polyethylene, polyester, polysulfide ethylene, polycarbonate, and acrylonitrile butadiene styrene (ABS) are used. Since the thermosetting resin has a three-dimensional molecular structure and is not melted even after heat is applied once, the thermoplastic resin is a chain polymer and melts when heat is applied after molding. Therefore, in the present invention, the thermoplastic resin Is preferably used. The thermoplastic resin is classified into an amorphous resin and a semi-crystalline resin, and the amorphous resin has a chain-like polymer bond. However, since the semi-crystalline resin has a regular molecular arrangement of a chain polymer bond, Ultrasonic welding is easier than that of a qualitative resin (e.g., polyamide, polyethylene, polypropylene, polyacetal, etc.).

Examples of the material of the hollow fiber membrane bundle include cellulose, cellulose derivatives, polymethylmethacrylate (PMMA), polypropylene, and polysulfone. However, when a hollow fiber membrane such as polysulfone is used for dialysis using only a hydrophobic polymer, control of the pore diameter is difficult, and blood components such as platelets adhere due to hydrophobicity, which is not suitable for blood compatibility. Therefore, the above problems can be solved by using hydrophilic polymers together. Specifically, the hydrophilic polymer may be previously incorporated as a pore forming agent in a stock solution to desorb a part of the hydrophilic polymer to form a pore, and then the surface of the polymer may be hydrophilized with the remaining hydrophilic polymer and used as the hollow fiber membrane.

As such a hydrophilic polymer, for example, polyethylene glycol, polyvinyl alcohol, carboxymethylcellulose, polyvinylpyrrolidone and the like are used, and they may be used alone or in combination. Polyvinylpyrrolidone is preferable because it is industrially relatively easy to obtain, has clinical evidence, and has high blood compatibility.

The material of the film-fixing layer may be a polymer material such as polyurethane, silicone, or epoxy, preferably a two-component mixture curing type polymer adhesive, and may be produced by centrifugal molding (potting) or the like.

A method of manufacturing a hollow fiber membrane module from the above materials will be described with reference to Fig. A plurality of hollow fiber membranes composed of a hollow fiber membrane polymer selected from the above materials are bundled and inserted into a main body case 3 molded by a known injection molding method or the like, After the cap 26 (see Fig. 6, for example) is attached, a film-fixing polymer selected from the above materials is injected into the end of the main body case 3 and the membrane- (4) is fixed to the main body case (3). After the film-fixing layer 5 is solidified, the membrane-fixing layer 5 is partially cut out so that both end faces of the hollow fiber membrane bundle 4 are opened outward, and a part of the membrane-fixing layer is cut off, The header 8 or 9 formed by a known injection molding method or the like is attached in a liquid tight manner by ultrasonic welding to produce a hollow fiber membrane module.

The present invention is characterized in that a liquid-tight structure is provided by ultrasonic welding in at least two regions extending over the entire periphery of the header and the main body case, and an important feature of the present invention is described with reference to Fig. 2 (a) do. In the following description, the ultrasonic welding is applied to the main body case 3 and the header 9, but the same applies to the case where the main body case 3 and the header 8 are ultrasonic welded.

As shown in Fig. 2 (a), the main body case 3 and the header 9 are integrally formed by an ultrasonic welded portion 10a made of a shear joint and an ultrasonic welded portion 10b made of a butt joint, do. The ultrasonic weld portion 10a and the ultrasonic weld portion 10b can be formed by ultrasonic welding at the same time. According to the present invention, the hollow fiber membrane module can be efficiently manufactured. 11 and 12 are resin reservoirs, and the resin melted by ultrasonic welding can be received in the resin reservoir, so that ultrasonic welding can be performed smoothly. The capacities of the resin reservoirs 11 and 12 are properly determined so as to be able to store the amount of molten resin from both joints, although they are not specifically defined because their proper values differ depending on the shape of the butt joint and the shear joint.

Joint design is very important to obtain liquid-tight structure by ultrasonic welding. In this joint design, a scarf joint that provides complete surface contact with the inclined surface, a bit joint that provides uniform heat generation to the joint portion due to surface contact in the vibration direction, and a bit joint that is intermediate between the scarf joint and the bit joint As shown in Fig. 4, since the contact surface and the vibration direction are close to the same direction with respect to the longitudinal vibration of the horn as a joint, it is difficult to generate air bubbles on the welded surface and the joint joints using energy directors And a butt joint in which energy is concentrated on a projection of a triangle called a director to raise the temperature to a resin melting temperature in a very short time to enable efficient welding.

In Fig. 3, H1 represents the deposition value, C represents the clearance of the upper and lower workpieces, and I represents the interferance dimension. In Fig. 4, W represents the width of the director and H2 represents the height of the director. In addition, although the butt joint is advantageous in that it is simple in shape and that the space of the joint portion can be relatively small, strong ultrasonic energy can not be generated in the longitudinal vibration welding method using the butt joint. On the other hand, it is possible to obtain high weld strength and liquid tightness by adopting a shear joint as a joint design of a semi-crystalline resin requiring strong ultrasonic energy without such incompatibility in a shear joint. The present invention can have a high bonding strength and an excellent liquid tightness by using a sheath joint and a butt joint in combination with this advantage.

In Fig. 2 (b), the width W2 of the shear joint is preferably 0.25 mm or more. The cross sectional area obtained by multiplying the width W2 of the shear joint by the height L2 is preferably 0.3 to 0.9 mm 2, more preferably 0.4 to 0.9 mm 2 for the above reasons.

In Fig. 2 (a), the distance L between the innermost periphery of the ultrasonic bonded portion 10b made of a butt joint and the inner peripheral surface of the header in the horizontal direction is preferably 0.5 to 2.0 mm for the above reason.

4, the area of the triangle (sectional area of the joint portion of the butt joint) obtained by multiplying the width W of the director by the half of the height H2 is preferably 0.05 to 0.35 mm 2 for the above reason.

In the hollow fiber membrane module of the present invention, a plurality of hollow fiber membranes made of a polymer for a hollow fiber membrane are bundled and inserted into a body case, a membrane fixing layer mold cap 26 is attached to the body case end, The hollow fiber membrane bundle was fixed to the main body case by injecting it into the end of the case to form a membrane immobilization layer. After the membrane immobilization layer was solidified, the membrane immobilization layer was partially cut so that both end faces of the hollow fiber membrane bundle were opened outward, And ultrasonic welding at the same time in at least two areas over the entire circumference of the main body case and the header after the cutout. In this manufacturing process, as shown in Fig. 2 (a), the cross section of the membrane-immobilized layer 5 at the portion where the plurality of hollow fiber membranes 4a are inserted is cut off so that both end faces of the hollow fiber membrane bundle 4 are opened outward The cross section of the membrane-immobilized layer 5 in this section is somewhat rougher than the cross section of the membrane-immobilized layer 5 which is not cut. Therefore, as shown in Fig. 2 (a), if the inner surface of the header 9 is not cut and is in contact with the end face of the film-fixing layer 5 having smoothness, liquid tightness can be further improved. The centerline average roughness (Ra) of the surface as an index of smoothness of the film-fixing layer 5 is preferably 50 탆 or less, more preferably 20 탆 or less. If the end face of the membrane-immobilized layer 5 is curved, a gap is formed between the inner circumferential faces of the contacting header 9, and the blood invades. Therefore, it is preferable that the height difference of the film-fixing layer 5 which is in contact with the inner circumferential surface of the header 9 is 100 mu m or less over the entire circumference. In addition, when a reverse taper that gradually extends toward the outward direction from the radially outer side toward the center side is applied to the film-fixing layer 5 in a range in contact with the inner side surface of the header 9, the header 9 and the film- The repulsive force of the blood vessels 5 is increased, and blood can be prevented from intruding more easily. The preferable angle of the reverse taper (? (? H / R) in FIG. 2 (c)) is 1 to 10 degrees, more preferably 2 to 6 degrees.

As described above, in the hollow fiber membrane module according to the present invention, ultrasonic welding is performed by using an excellent butt joint and an efficient butt joint having excellent versatility in at least two regions extending over the entire periphery of the header and the main body case to improve liquid tightness, The bonding strength of the portion can be increased. As shown in Fig. 7, in order to prevent the intrusion of blood into the gap 36 between the header 32 and the membrane-immobilization layer 35, The hollow fiber membrane module of the present invention is excellent in liquid tightness, and thus the cyclic elastic body 37 may be omitted.

The ultrasonic welding apparatus usable in the present invention is not limited, but an apparatus with a frequency of 15 kHz to 60 kHz is preferable. In addition, when a device having a frequency of about 15 kHz to 40 kHz is used, vibration can be easily transferred to the adherend, so that good transfer welding is possible. For example, an apparatus as shown in Fig. 5 can be exemplified. 5, the vibrator 22 vibrates by receiving a signal generated by the oscillator 21, and the horn 23 amplifies the vibration to a predetermined amplitude. The horn 23 is pushed against the header 8 by the actuator 24 and transmits the ultrasonic vibration to the ultrasonic welded portion 10 of Fig.

The adherend of the header collides with the adherend of the main body case 3 under pressure by the horn. In addition, by applying ultrasonic vibration while applying pressure, the interface between the adhered portions rapidly generates heat and starts melting. The molten resin starts to dissolve in the surrounding space. Further, by applying pressure and ultrasonic vibration, the adherend is dissolved. When the ultrasonic vibration is stopped after the portion to be adhered reaches a desired dissolving amount, cooling of the adherend progresses, and the header 8 and the body case 3 are fixed.

The pressing force is not particularly specified because the proper value is different according to the material of the header and the body case and the shape of the welded portion. Generally, when the entire circumference of a cylindrical container having a diameter of 60 mm is welded, a pressing force of about 0.2 to 0.6 MPa . In the case where the material of the header is polypropylene or polyethylene, if the pressing force is excessively large, deformation of the header may occur or heat other than the adherend may be generated. Therefore, have.

In Fig. 5, the hollow fiber membrane module is held in the receiving chamber 25. Fig. The result of the deposition can be stabilized by holding the hollow fiber membrane module in the receiving chamber 25 as shown in Fig. 5 so that vibration is uniformly transmitted. The installation direction of the welder is not specifically defined, for example, when the horn is provided below the main body case or when the horn is provided above the main body case. However, in either case, the cohesion of the header and the main body case is adjusted, Therefore, it is preferable.

Example

However, the present invention is not limited to the following embodiments, and various modifications and changes may be made without departing from the technical scope of the present invention.

(Example 1)

A polypropylene case having an overall length of 285 mm, an inner diameter of 34.8 mm, an end inner diameter of 44.2 mm and an end outer diameter of 48.2 mm was attached to a case (reference numeral 3 in Fig. 9,200 bundles of hollow fiber membranes were inserted so that both ends of the hollow fiber membranes protruded at least 7 mm from the ends of the body case, and a carbon dioxide gas laser with an output of 80 W was irradiated to the end faces at both ends in a predetermined pattern, And the hollow portion was sealed. Subsequently, a cap (see reference numeral 26 in Fig. 6) is attached to both ends of the main body case, and a centrifugal force generated by rotating the main body case such that the half of the total length of the main body case is set as a rotation center axis, (See reference numeral 1 in Fig. 1) of the treatment liquid and the exit port (reference numeral 2 in Fig. 1) of the treatment liquid to cure the urethane resin injected from both ends of the body case to form a membrane- The bundle and the body case were fixed. The membrane-fixing layer was 44.2 mm in diameter at the case end, was linearly reduced in diameter to 41 mm from the case end portion to 0.1 mm in the outward direction, and extended to a maximum of 7.4 mm outwardly from the position. However, in the vicinity of the inner circumferential surface of the end portion of the main body case, there was a film fixing layer portion having a protruding amount in the outward direction from the case end portion of less than 0.5 mm. The membrane-fixing layer was cut at a position 0.5 mm outward from the end of the main body case so as to be orthogonal to the axial direction of the main body case to form a cross-section of the membrane-fixing layer and open the hollow fiber membrane. Thereafter, a header made of polypropylene (see reference numerals 8 and 9 in Fig. 1) and the main body case were ultrasonically welded under the conditions of a frequency of 20 kHz, a pressing force of 0.35 MPa, a welding time of 0.7 seconds, and a holding time of 1.0 second. Herein, the inner circumferential surface of the header was subjected to ultrasonic welding while pressing against the surface of the fixed film layer formed by the non-cut surface outside the cut surface of the fixed layer, that is, the inner surface of the cap. The gap is reduced by pressing the inner circumferential surface of the header against the surface of the film fixing layer formed by the inner surface of the cap, and the ultrasonic welding This is possible.

In this embodiment, as shown in Fig. 6, since the cap 26 having a shape in which a part of the periphery of the end face does not protrude 0.5 mm outward from the main case end is used, The outer periphery is not cut off and the surface of the film fixed layer formed by the inner surface of the cap remains as it is.

As a result of the disassembly of the welded intermediate product, the inner diameter D0 of the header (see numeral 9 in Fig. 2 (a)) was 41.5 mm, and the tip joint diameter (see reference numeral 10b in Fig. The welding depth W1 is 0.5 mm and the inner diameter D2 is 47.4 mm for the second joint portion (refer to 10a in Fig. 2 (a)). , The deposition depth L2 is 1.2 mm and the deposition width W2 is 0.4 mm and the first resin reservoir (see reference numeral 12 in Fig. 2 (a)) has a width of 0.5 mm and a height of 1 mm, (See reference numeral 11 in Fig. 2 (a)) was 0.9 mm in width and 1 mm in height (see Fig. 2 (b)). The width of the joint of the second joint portion was 0.4 mm, the cross-sectional area of the second joint portion was 0.48 mm 2, the horizontal distance between the innermost periphery of the first joint and the inner peripheral surface of the header was 1.55 mm, and the cross- (See reference numeral 1 in Fig. 1) and an outlet port (reference numeral 1 in Fig. 1) of an object to be treated and an outlet port ) Were packaged and packaged and subjected to gamma-sterilization, thereby completing a blood treatment apparatus having an effective membrane area of 1.5 m < 2 >.

A dialyzate solution was added to the treatment solution side of the blood treatment device thus prepared, and a liquid in which the solution to be treated was mixed with the ratio of bee: physiological saline at a ratio of 1:10 was filled. Thereafter, a liquid-tight substance (not shown) is supplied to an inlet port of the treatment liquid (see reference numeral 1 in Fig. 1), an outlet port of the treatment liquid (see reference numeral 2 in Fig. 1) A manual pressurizing pump was connected to the inlet port of the object to be treated (see reference numeral 6 in FIG. 1) by a hose, and a pressure of 10 psi was applied to the blood processor by a pressurizing pump, (See reference numeral 8 and 9 in Fig. 1) and the film-fixing layer (see reference numeral 5 in Fig. 1), the internal pressure is increased by 10 kPa until the penetration of the liquid is confirmed, . This evaluation was carried out for each of the five blood treatment apparatuses manufactured as described above, and the infiltration was observed at an average internal pressure of 508 kPa and a minimum internal pressure of 220 kPa for five times.

(Example 2)

A polypropylene body case having an overall length of 285 mm, an inner diameter of 45.2 mm, an inner diameter of 54.8 mm and an outer diameter of 58.8 mm was hollowed with 16,000 hollow fiber membranes of an inner diameter of 200 탆 and a thickness of 40 탆 The desiccant bundle was inserted so that both ends thereof protruded at least 7 mm from the end of the main body case, and a carbon dioxide gas laser with an output of 80 W was irradiated to the end faces at the both ends in a predetermined pattern to seal the hollow portion in the end face of the hollow fiber membrane. Then, a cap (see Fig. 6) is attached to both ends of the main body case (see reference numeral 3 in Fig. 1), and the half of the total length of the main body case is set as the rotation center axis, (See reference numeral 1 in Fig. 1) and an outlet port (reference numeral 2 in Fig. 1) of the treatment liquid are cured by using the centrifugal force generated by rotating the membrane- And the hollow fiber membrane bundle and the main body case were fixed. The membrane-fixing layer was 54.8 mm in diameter at the case end, extended outwardly with a diameter of 54.8 mm from the case end to 1 mm in the outer direction, was linearly reduced to 51.6 mm from the position in the outer direction by 0.1 mm , And further extended in the outward direction by 6.4 mm at the maximum from the position. However, in the vicinity of the inner circumferential surface of the end portion of the main body case, there was a portion of the film fixing layer whose protrusion amount in the outward direction was less than 1.5 mm. The membrane-fixing layer was cut at a position 1.5 mm outward from the end of the main body case so as to be orthogonal to the axial direction of the main body case to form a cross section of the membrane-fixing layer and open the hollow fiber membrane. Thereafter, a header made of polypropylene (see reference numerals 8 and 9 in Fig. 1) and the main body case were ultrasonically welded under the conditions of a frequency of 20 kHz, a pressing force of 0.4 MPa, a welding time of 0.7 seconds, and a holding time of 1.0 second. In this Example 2, similarly to Example 1, the inner circumferential surface of the header was subjected to ultrasonic welding while being pressed against the surface of the film fixing layer formed by the non-cut surface outside the cut surface of the film fixing layer, that is, the inner surface of the cap.

As a result of disassembling the welded intermediate product, the inner diameter D0 of the header (see numeral 9 in Fig. 2 (a)) is 52.1 mm, and the inner diameter of the first joint portion (see 10b in Fig. The inner diameter D2 is 58 mm for the second joint portion (refer to reference numeral 10a in FIG. 2 (a)), the weld depth D1 is 55.0 mm, the weld depth L1 is 0.5 mm and the weld width W1 is 0.5 mm. , The deposition depth L2 is 1.2 mm and the deposition width W2 is 0.4 mm and the first resin reservoir portion (see reference numeral 12 in Fig. 2 (a)) has a width of 0.4 mm and a height of 0.7 mm, (See reference numeral 11 in Fig. 2 (a)) was 1 mm wide and 0.7 mm high (see Fig. 2 (b)). The width of the joint of the second joint portion was 0.4 mm, the cross-sectional area of the second joint portion was 0.48 mm 2, the horizontal distance between the innermost periphery of the first joint portion and the inner peripheral surface of the header was 1.45 mm, and the cross-sectional area of the first joint portion was 0.125 mm 2. (See reference numeral 1 in Fig. 1) and an outlet port (reference numeral 1 in Fig. 1) of an object to be treated and an outlet port ), Respectively, and wrapped with gamma-ray sterilization to complete a blood treatment apparatus having an effective membrane area of 2.6 m 2.

As a result of the pressure resistance test as in Example 1, permeation was observed at an average internal pressure of 262 kPa and a minimum internal pressure of 130 kPa five times.

(Comparative Example 1)

A blood processor was completed in the same manner as in Example 1 except that the first joint portion (refer to 10b in FIG. 2 (a)) was not used, and a header having the same shape as in Example 1 was used. The cross-sectional area obtained by multiplying the width of the joint of the second joint portion by the height was 0.48 mm 2, and the horizontal distance between the innermost periphery of the second joint portion and the inner peripheral surface of the header was 2.95 mm. As a result of the pressure resistance test as in Example 1, penetration was observed at an average internal pressure of 30 psi and a minimum internal pressure of 0 psi for five times.

(Comparative Example 2)

The tip diameter D1 is 45 mm, the welding depth L1 is 0.7 mm and the welding width W1 is 1.1 mm with respect to the first joint portion (see reference numeral 10b in FIG. 2 (a) (See reference numeral 10a in Fig. 2 (a)) and the first resin reservoir portion (refer to reference numeral 12 in Fig. 2 (a)) has a width of 0.6 mm and a height of 0.8 mm, (See reference numeral 11 in the figure) was a header having the same shape as in Example 1 except that the width was 0.6 mm and the height was 0.8 mm. The cross-sectional area of the first joint portion was 0.493 mm 2, and the horizontal distance between the innermost periphery of the first joint portion and the inner peripheral surface of the header was 1.75 mm. As a result of the pressure resistance test as in Example 1, penetration was observed at an average internal pressure of 69 kPa and a minimum internal pressure of 0 kPa five times.

(Comparative Example 3)

A header having the same shape as in Example 1 was used except that the first resin storage portion (refer to reference numeral 12 in Fig. 2 (a)) and the second resin storage portion (refer to reference numeral 11 in Fig. 2 The blood processor was completed. The width of the joint of the second joint portion was 0.4 mm, the cross-sectional area of the second joint portion was 0.4 mm 2, the horizontal distance between the innermost periphery of the first joint and the inner peripheral surface of the header was 1.55 mm, and the cross-sectional area of the first joint portion was 0.075 mm 2. As a result of performing the same withstand voltage test as in Example 1, penetration was observed at 0 占 at any of five times of the withstand test. When the blood processor was cut in the longitudinal direction, the resin melted was filled between the header and the main body case section, and a clearance of 0.1 to 0.2 mm was seen between the inner peripheral surface of the header and the membrane fixing layer.

(Comparative Example 4)

A cap having a shape different from that of Embodiment 1 was used at the time of forming the membrane pinning layer. As a result, the diameter at the end portion of the main body case was 44.2 mm and the maximum length was 7.5 mm from the end portion of the case, Of the film-fixing layer formed so as to be perpendicular to the axial direction of the main body case at a position 0.5 mm outward from the case end with respect to the film-holding layer formed so that the amount of protrusion from the case end portion in the outward direction is 0.5 mm or more A blood processor was completed in the same manner as in Example 1 except that the main body case and the ultrasonic welding were performed so as to press the inner peripheral surface of the header. That is, unlike Examples 1 and 2 and Comparative Examples 1 to 3, when the ultrasonic welding was performed only in Comparative Example 4, the inner peripheral surface of the header was pressed against the cut surface of the film fixing layer. The width of the joint of the second joint portion was 0.4 mm, the cross-sectional area of the second joint portion was 0.48 mm 2, the horizontal distance between the innermost periphery of the first joint and the inner peripheral surface of the header was 1.55 mm, and the cross- This blood processor was subjected to the same pressure-resistant test as in Example 1, and as a result, penetration was observed at 0 ° C in any of the pressure-resistance tests five times. As a result of cutting the penetrated portion in the longitudinal direction, a clearance of 0.1 to 0.3 mm was seen between the inner peripheral surface of the header and the fixed film layer.

(Comparative Example 5)

The same header as in Example 2 was used except that the tip diameter D1 of the first joint portion was 55.2 mm, the welding depth L1 was 0.3 mm, and the welding width W1 was 0.3 mm. To complete the blood processor. The width of the joint of the second joint portion was 0.4 mm, the cross-sectional area of the second joint portion was 0.48 mm 2, the horizontal distance between the innermost periphery of the first joint and the inner peripheral surface of the header was 1.55 mm, and the cross- As a result of the pressure resistance test as in Example 1, penetration was observed at an average internal pressure of 55 kPa and a minimum internal pressure of 0 kPa five times. As a result of cutting the penetrated portion in the longitudinal direction, the first joint portion was crushed and deformed, and substantially the header and the case were not welded together.

(Comparative Example 6)

A blood treatment apparatus was completed in the same manner as in Example 2 except that the main body case made of polypropylene was heated in an oven at a temperature of 50 占 폚 for 30 minutes to shrink the end inner diameter to 54.4 mm and the end outer diameter to 58.4 mm. The width of the joint of the second joint portion was 0.2 mm, the cross-sectional area of the second joint portion was 0.24 mm 2, the horizontal distance between the innermost periphery of the first joint and the inner peripheral surface of the header was 1.55 mm, and the cross- However, bubbles were partially formed in the second joint portion, so that they were not welded normally. As a result of the pressure resistance test as in Example 1, penetration was observed at an average internal pressure of 48 psi and a minimum internal pressure of 10 psi for five times.

1: Inlet port of treatment liquid 2: Outlet port of treatment liquid
3: Body case 4: Hollow fiber membrane bundle
4a: Hollow fiber membrane 5: Membrane fixing layer
6: inlet port of the liquid to be treated 7: outlet port of the liquid to be treated
8: Header 9: Header
10: ultrasonic welding portion 10a: ultrasonic welding portion of shear joint
10b: Ultrasonic welded part of butt joint 11: Resin holding part
12: resin reservoir 21: oscillator
22: Oscillator 23: Horn
24: actuator 25:
26: Cap 31: Body container
32: Header 33: Ultrasonic Welding Part
34: ultrasonic welding portion 35: membrane fixing layer
36: gap 37: annular elastic body

Claims (8)

A membrane-fixing layer for fixing the hollow fiber membrane bundle to the inner wall of the end portion of the main body case; and an inlet or outlet for introducing the liquid to be adhered to the case opening end, And having a liquid-tight structure by ultrasonic welding in at least two regions over the entire periphery of the header and the main body case,
As a joint design for ultrasonic welding the side surface of the outer periphery of the main body case and the inner side surface of the header over a whole circumference, a sheath joint is used and a butt joint is used for ultrasonic welding the end surface of the main body case and the inner side surface of the header. Wherein the hollow fiber membrane module is a hollow fiber membrane module. The method according to claim 1,
Wherein the cross-sectional area of the hollow fiber membrane module obtained by multiplying the width of the joint in the shear joint by the height is 0.3 to 0.9 mm 2. The method according to claim 1,
Sectional area obtained by multiplying the width of the joint in the shear joint by the height is 0.4 to 0.9 mm < 2 >. 4. The method according to any one of claims 1 to 3,
And the horizontal distance between the innermost periphery of the butt joint and the inner periphery of the header is 0.5 to 2.0 mm. 5. The method according to any one of claims 1 to 4,
Wherein an area of the triangle obtained by multiplying the width of the director in the butt joint by a half of the height is 0.05 to 0.35 mm < 2 >. 6. The method according to any one of claims 1 to 5,
And the resin reservoir portion is provided on both the inner circumferential side and the outer circumferential side of the butt joint. A membrane-fixing layer for fixing the hollow fiber membrane bundle to the inner wall of the end portion of the main body case; and an inlet or outlet for introducing the liquid to be adhered to the case opening end, And a method of manufacturing a hollow fiber membrane module in which ultrasonic welding is simultaneously performed in at least two areas extending over the entire periphery of the header and the main body case,
Characterized in that the side face of the outer case of the main body case and the inner side face of the header are ultrasonically welded by a shear joint and the end face of the main body case and the inner side face of the header are ultrasonically welded by the butt joint over the entire circumference. Gt; A plurality of hollow fiber membranes made of a polymer for hollow fiber membranes are bundled and inserted into a main body case, a membrane fixing layer cap is attached to the end of the main body case, and then a membrane fixing layer polymer is injected into the main body case end, The bundle is fixed to the main body case, the membrane-fixing layer is partially cut so that both end faces of the hollow fiber membrane bundle are opened outward after the film-fixing layer is solidified, and the main body case and the header A hollow fiber membrane module manufactured by simultaneously ultrasonic welding in at least two areas,
Characterized in that the inner surface of the header is in contact with the end face of the membrane-immobilized layer which is not cut off.

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